Responsible for performing various routine manufacturing tasks following established procedures and cGMP regulations under guidance of a production supervisor and/or senior management.
ESSENTIAL DUTIES & RESPONSIBILITIES
- Follow production and manufacturing procedures.
- Perform equipment preparation, bulk drug formulation, and aseptic filling duties as needed.
- Accurately document data and complete batch records as needed.
- Perform cleaning and sanitization duties as instructed by the applicable procedure.
- Successfully complete facility’s aseptic gowning and manufacturing qualification program.
- Execute validation protocols as needed.
- Train in various manufacturing tasks including, but not limited to: fill/finish, formulation, lyophilization, sanitization, component and equipment preparation, and finished product inspection and packaging activities.
- Perform duties in ISO 4.8, ISO 6, ISO 7, and ISO 8 cleanrooms.
- Perform routine maintenance of production equipment.
- Assist in maintaining a warehouse that adheres to FDA regulations. This includes but is not limited to: hand truck and fork lift operation, sanitization, labeling, and staging.
- Support Agency, customer and vendor audits as needed.
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
- Perform all other tasks, projects, and duties as assigned.
DESIRED SKILLS & ABILITIES
- Ability to be detail-oriented.
- Strong written and verbal communication skills.
- Ability to work independently, within prescribed guidelines, or as a team member.
- Familiar with Microsoft Office applications.
- Proficiency in both written and verbal communication and presentations.
- Energetic, self-motivated, organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
- Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.
- Ability to work closely with a diverse customer base (internally and externally).
- Ability to work well in a cross-functional team environment.
- Must have proficient computer skills in Microsoft Word, Excel and Outlook.
EDUCATION, PRIOR EXPERIENCE, & TRAINING
Minimum of a high school diploma and zero to one (0-1) year relevant experience in manufacturing or a laboratory environment is required.
Bachelor’s degree, or equivalent experience is preferred.